Neothetics, Inc.’s LIPO-202 for the reduction of submental subcutaneous fat failed to demonstrate improvement on any efficacy measurements or separation from placebo in a Phase 2 proof-of-concept trial.
Neothetics Inc. shares dropped 66% in premarket trade Monday on news of negative results for its fat-reduction drug.
“We are disappointed in these results, which are unambiguous,” said Dr. Dan Piacquadio, head of Neothetics’ Development Committee, in a news release.
This same drug also failed to past muster in a December 2015 study that looked at its use in reducing subcutaneous fat in the abdominal area.
LIPO-202-CL-31 was a multi-center, randomized, double-blind, placebo-controlled Phase 2 proof of concept trial to evaluate the safety and efficacy of two doses of LIPO-202 versus placebo for the reduction of submental bulging due to subcutaneous fat. The trial enrolled 162 subjects at 12 sites across the United States. Subjects were randomized 1:1:1 and received up to either 0.3 mcg, or 3.0 mcg dose of LIPO-202, or placebo. Subjects received up to 30 subcutaneous injections of LIPO-202 or placebo once a week for eight weeks and follow up visits to assess safety and efficacy occurred one week and four weeks post the last treatment.
The study endpoints included both safety and efficacy measurements. Efficacy measures assessed improvement in the subject’s submental region as evaluated by both the patient and clinician, covering overall subject satisfaction and evaluation of submental fat thickness by calipers.
Neothetics had $9.7M in cash as of the end of the first fiscal quarter in 2017.